Canine-Assisted ANxiety Reduction IN Emergency Care IV

Chronic Pain Clinical Trial

— CANINE IV  

Official title:

Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04287452
• Other study ID #: 001968358
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;

• decrease reported anxiety levels in emergency department (ED) patients,

• decrease salivary cortisol in ED patients,

• decrease total morphine equivalent dosing in the emergency department or at discharge and/or,

• decrease reported stress levels in emergency department providers caring for participating patients

when compared to usual care.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients

• Age 18-89 years

• Chronic pain, defined as pain on most days for >6 weeks

• Triage pain score >6 out of 10

OR

• Age 18-89 years

• Currently experience crisis, including suicidality, or

• Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale

Providers

• Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.

Therapy Dog Handlers

• Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program

Exclusion Criteria:

Patients

• Violent behavior

• Overt intoxication

• Non-English speaking

• Any reported prior fear or adverse reaction to dogs

Providers

• Any reported prior fear or adverse reaction to dogs

Therapy Dog Handlers

• None

Related Conditions & MeSH terms

• Anxiety Acute
• Anxiety Disorders
• Chronic Pain
• Emergencies

Intervention

Other:
• Control
Control
• Dog Therapy
Exposure to certified therapy dogs and their handler.

Locations

Country	Name	City	State
United States	Eskenazi Health System	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Healthcare Initiatives, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797. — View Citation

Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3. — View Citation

Havey J, Vlasses F, Vlasses P, Ludwig P, Hackbarth D. The Effect of Animal-Assisted Therapy on Pain Medication Use After Joint Replacement. Anthrozoos 2014; 27: 361-369.

Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014 Oct 14;14:219. doi: 10.1186/1472-6920-14-219. — View Citation

Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21. — View Citation

Munoz Lasa S, Maximo Bocanegra N, Valero Alcaide R, Atin Arratibel MA, Varela Donoso E, Ferriero G. Animal assisted interventions in neurorehabilitation: a review of the most recent literature. Neurologia. 2015 Jan-Feb;30(1):1-7. doi: 10.1016/j.nrl.2013.01.012. Epub 2013 May 1. English, Spanish. — View Citation

Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine equivalent narcotic administration in emergency department patients with chronic pain	Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.	Date of enrollment until emergency department discharge, up to 72 hours
Primary	Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)	Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Primary	Change in salivary cortisol in ED patients with chronic pain	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Primary	Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis	Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis	Date of enrollment until emergency department discharge, up to 72 hours
Primary	Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)	Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Primary	Change in salivary cortisol in ED patients with emotional crisis	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Secondary	Change in salivary cortisol levels in emergency department patients	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)